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INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS® FAMILY OF IOLs

CAUTION

Federal law restricts this device to sale by or on the order of a physician.

ATTENTION

Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

TECNIS® MONOFOCAL 1-PIECE IOL

INDICATIONS

The TECNIS® 1-Piece lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

WARNINGS

Existing eye conditions and surgical difficulties may increase the risk of complications. Your doctor will determine if you are a good candidate for lens replacement. Read more Important Safety Information.

TECNIS® TORIC 1-PIECE IOL

INDICATIONS

The TECNIS® Toric 1-Piece posterior chamber lens is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.

RISKS

No matter what lens you choose, there are risks or problems that can happen with cataract surgery. The problems could be minor, temporary, or affect your vision long term. Complications with cataract surgery are rare and may include the worsening of your vision, bleeding, or infection. Read more Important Safety Information.

TECNIS® MULTIFOCAL FAMILY OF 1-PIECE IOLs

INDICATIONS

The TECNIS® Multifocal 1-Piece intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag.

RISKS

No matter what lens you choose, there are risks or problems that can happen with cataract surgery. The problems could be minor, temporary, or affect your vision permanently. Complications are rare and may include the worsening of your vision, bleeding, or infection. There are also tradeoffs with receiving a multifocal lens. Whereas your use of glasses may decrease, it may come at the cost of some sharpness of your vision. Even with glasses, this loss of sharpness may become worse under poor visibility conditions such as dim light or fog. Read more Important Safety Information.

TECNIS SYMFONY and TECNIS SYMFONY TORIC EXTENDED RANGE OF VISION IOLs

INDICATIONS FOR USE

The TECNIS Symfony Extended Range of Vision IOL, Model ZXR00, is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The Model ZXR00 IOL is intended for capsular bag placement only.

The TECNIS Symfony Toric Extended Range of Vision IOLs, Models ZXT150, ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed.The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The Model Series ZXT IOLs are intended for capsular bag placement only.

CONTRAINDICATIONS

None.

RISKS

Routine cataract surgery risks, irrelevant to lens selection, could be minor, temporary, or affect patients' vision permanently. Rare complications are worsening of vision, bleeding, or infection. Risks related to use of this lens include a slight loss in vision sharpness with decreased use of glasses. Even with glasses, loss of sharpness may worsen under poor visibility conditions such as dim light or fog. This may lead to driving difficulties, and not detecting road hazards as quickly at night or in fog. Patients may also notice halos, starbursts, glare, and other visual symptoms with extended range of vision IOLs. This may impact patients when there are bright lights at night. Patients should discuss all risks and benefits with their eye doctor before surgery.

WARNINGS

A small number of patients may want their Tecnis Symfony IOL removed because of lens-related optical/visual symptoms. Patients with pre-existing diseases or conditions (i.e., diabetes and heart disease) may have higher risk of experiencing complications (e.g., more difficult recovery) after routine cataract surgery. Patients should not receive this lens if they have had previous trauma to their eye. Not evaluated for use in children.

PRECAUTIONS

If the patient's eye is unhealthy (including glaucoma), vision may not be good even after cataract removal; patients may not get full benefit of the Tecnis Symfony IOL. Before surgery, the eye doctor will check for any eye diseases. Patients' vision with the IOL may not be good enough to perform detailed 'up-close' work without glasses, and rarely, may make some types of retinal treatment (e.g., retinal tear repair) more difficult. Patients should take all prescribed medicines and apply eye drops as instructed to avoid inflammation and infection. Patients should avoid bending down and playing sports, which can harm the eye during recovery. The eye doctor will tell patients what activities to avoid.